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Found 5 results
510(k) Data Aggregation
K Number
K993349Device Name
NIL, SURGEON'S GLOVE - POWDER FREE
Manufacturer
Date Cleared
1999-11-23
(49 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
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K Number
K993347Device Name
NIL, NITRILE EXAMINATION GLOVE - POWDERED
Manufacturer
Date Cleared
1999-11-19
(45 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile Examination Glove is a disposable device made of Nitrile Latex intended for medi purpose, that is worn on the examiners hand or linger to prevent contamination between patie and Examiner.
Device Description
Class I Patient Examination (Floves ( Nitrile) 801 7.A that meets all 'the requirements of ASTM D3578- 95.
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K Number
K993348Device Name
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
Manufacturer
Date Cleared
1999-11-19
(45 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile examination glove (Powder free) is a Powder free devices made of Nitrile Latex intent for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Device Description
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
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K Number
K984395Device Name
SURGEON'S GLOVES
Manufacturer
Date Cleared
1999-05-21
(164 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgeon's Glove is a medical device intended to be worn by operating room personnel during surgery to protect a surgical wound from contamination.
Device Description
Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO that meets all the requirements of ASTM D 3577 - 91. Type 1 - Gloves compounded primarily from Natural Rubber Latex.
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K Number
K983998Device Name
POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
1999-01-21
(73 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fowder Free Latex Examination Glove is a device intended for medical use , worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner.
Device Description
Class 1- Patient Examination Gloves(Powder Free) ROL YY that meets all the requrements ASTM D 3578-95.
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